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FDA grants Fast Track designation to two COVID-19 vaccines
Two investigational SARS-CoV-2 vaccine candidates, BNT162b1 and BNT162b2, currently in clinical trials have been granted Fast Track designation by the FDA.
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Regulation & Legislation
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NICE recommends Adcetris (brentuximab vedotin) for treatment of rare lymphoma
The recommendation of Adcetris (brentuximab vedotin) represents the first new frontline therapy for systemic anaplastic large cell lymphoma (sALCL) in several decades.
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FMD alerts in 2020 – where we are a year into legislation
Over a year since the EU FMD came into force, false alerts remain a problem preventing the realisation of the full benefits of the directive. Grant Courtney examines the reasons behind these alerts occurring and looks at the action stakeholders must now take.
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EMA issues opinion on nitrosamines in medicines
The agency’s opinion will require companies to take measures to reduce nitrosamine impurities in medicines and carry out and action the results of risk assessments.
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Cervical dysplasia treatment device approved for global Phase III trial
The cervical dysplasia drug-device product, APL-1702 (Cevira®), offers an alternative to surgery and has been approved to start a clinical trial in China and several other countries.
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India approves remdesivir for restricted emergency use in COVID-19 patients
The Drug Controller General of India (DCGI) approved remdesivir lyophilised powder for emergency use in patients hospitalised with severe COVID-19.
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Expanded access for compassionate use of remestemcel-L in COVID-19 infected children
US expands access to remestemcel-L for compassionate use in COVID-19 infected children with complications of multisystem inflammatory syndrome.
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How to start up an ATMP clinical trial
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…
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FDA approves new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring
Abbott’s Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices are given approval.
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EMA recommends Idefirix (imlinfidase) is granted marketing authorisation
The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
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CHMP recommends cystic fibrosis treatment Kaftrio is granted marketing authorisation
The European Medicines Agency's human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.
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Comparison of health technology assessments and time to reimbursement for Orphan Drugs
This article delves into four health technology assessment agencies, analysing the opportunities and challenges for orphan drugs in France, Germany, England and Scotland.
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FDA approves new administration route for Phesgo to treat breast cancer
The FDA has given approval to Phesgo for injection under the skin to treat HER2-positive breast cancer, meaning it can be administered at home by a healthcare professional.
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NICE does not recommend Novartis’ siponimod for secondary progressive MS
NICE has decided to not recommend Mayzent (siponimod) for use on the NHS as a secondary progressive multiple sclerosis treatment because its clinical trial did not directly compare it to interferon beta-1b.
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Application note: Ozonia Ozone Technology for ultrapure water disinfection
Learn why Ozonia MEMBREL electrolytic ozone technology is the ultimate solution for ultrapure water disinfection applications.
